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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICE CREEK MFG TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC
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RICE CREEK MFG TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CMRM6133
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ddmc3d4 icd, implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient experienced an infection one month post implant of an implantable cardioverter defibrillator (icd) with an absorbable envelope.The icd system was explanted and replaced.No further patient complications have been reported as a result of this event.
 
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Brand Name
TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
RICE CREEK MFG
7000 central ave ne
fridley MN 55432
MDR Report Key10048477
Report Number6000030-2020-00166
Device Sequence Number3357587
Product Code FTL
UDI-Device Identifier00763000101619
UDI-Public00763000101619
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date04/30/2020
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR126814
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/29/2020
Initial Report FDA Received Date05/12/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
6947M62 LEAD, 559453 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age72 YR
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